U.S. patent application number 10/767304 was filed with the patent office on 2004-09-23 for triclosan containing absorbable sutures with extended antimicrobial properties.
Invention is credited to John, Amy T..
Application Number | 20040185250 10/767304 |
Document ID | / |
Family ID | 32994311 |
Filed Date | 2004-09-23 |
United States Patent
Application |
20040185250 |
Kind Code |
A1 |
John, Amy T. |
September 23, 2004 |
Triclosan containing absorbable sutures with extended antimicrobial
properties
Abstract
Triclosan containing absorbable antimicrobial sutures with
extended antimicrobial properties were disclosed. Triclosan can be
incorporated into the absorbable sutures by coating, soaking,
soaking and coating of triclosan containing solutions or adding
triclosan into absorbable polymers before they are processed into
fibers.
Inventors: |
John, Amy T.; (Raleigh,
NC) |
Correspondence
Address: |
Amy John
2308 Wakefield Plantation Dr.
Raleigh
NC
27614
US
|
Family ID: |
32994311 |
Appl. No.: |
10/767304 |
Filed: |
January 30, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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60445578 |
Feb 7, 2003 |
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Current U.S.
Class: |
428/364 |
Current CPC
Class: |
Y10T 428/2913 20150115;
A61B 2017/00004 20130101; A61B 17/06166 20130101 |
Class at
Publication: |
428/364 |
International
Class: |
B32B 003/00 |
Claims
What is claimed is:
1. Triclosan containing absorbable sutures exhibiting extended
antimicrobial activity retention and desirable handling
characteristics.
2. Absorbable sutures according to claim 1, by a process comprising
coating with a mixture comprising triclosan which is either added
into the coating mixture or incorporated into the coating carrier
polymers, one or more absorbable carrier polymers with or without
triclosan and one or more fatty acid salts or treating non-coated
sutures with a solution of triclosan, and coating with a mixture
comprising one or more absorbable carrier polymers and one or more
fatty acid salts with or without triclosan.
3. Absorbable sutures according to claim 1 by a process comprising
incorporating triclosan into the absorbable polymers, spinning,
braiding, and coating with a mixture comprising one or more
absorbable carrier polymers and one or more fatty acid salts with
or without triclosan.
Description
FIELD OF THE INVENTION
[0001] This invention relates to triclosan containing absorbable
sutures with extended antimicrobial properties and desirable
handling characteristics.
BACKGROUND
[0002] Coating medical devices with pharmaceutical agents is well
documented in the art. Such coated devices could theoretically
provide means for locally delivering pharmaceutical or therapeutic
agents at the site of medical intervention. For example, sutures
coated with antibiotics can deliver these bioactive agents directly
to implantation site, therefore, reducing the possibility of
infection following the surgical intervention.
[0003] There are generally two methods of coating a medical device,
such as absorbable sutures, with antimicrobial agents: 1) placing
the medical device into a solution containing an antimicrobial
agent until it is bound or soaked into the device as described in
U.S. Pat. No. 3,987,797 and No. 4,024,871 and also in a recent
patent application assigned to Ser. No. 20020055759; or 2) coating
the device with a polymeric matrix containing antimicrobial agents.
U.S. Pat. No. 5,378,540 describes compositions for coating a
surgical suture with a biodegradable polycaprolactone polymer,
optionally containing a pharmaceutical agent.
[0004] However, prior art methods of antimicrobial absorbable
sutures have typically been limited with respect of the types
antimicrobial agents incorporated into the devices or
unsatisfactory effect of the coating on the performances of the
devices coated or relatively short retention of antimicrobial
activity. Accordingly, there remains a need in the art for
compositions and methods for absorbable antimicrobial sutures with
adequate antimicrobial activity and equally importantly, the coated
devices maintain their desirable performance characteristics.
[0005] Triclosan is a widely used antimicrobial agent found in
various household products and medical field. It is one of the most
efficacious biocides against staphylococcus at extremely low
levels. It has also been used successfully in treatment regimens to
eliminate topical infections with methicillin-resistant bacteria.
The susceptibility of the most common device-related pathogens
combined with inherently low toxicity makes triclosan a favorable
candidate for absorbable antimicrobial suture application.
SUMMARY OF THE INVENTION
[0006] Absorbable sutures, having desirable antimicrobial
properties and handling characteristics, are obtained by
incorporating triclosan and proper coating of the devices.
DESCRIPTION OF PREFERRED EMBODIMENTS
[0007] One aspect of the present invention is the compositions of
absorbable antimicrobial sutures, comprising absorbable polymers,
such as homopolymers or copolymers of glycolide, lactide,
caprolactone, dioxanone or trimethylene carbonate, triclosan and
also one or more fatty acid salts, such as stearic acid calcium or
sodium salts or stearic acid esters and related salts. The
antimicrobial agent is triclosan and the fatty acid salts, in the
form of calcium or sodium salts or esters and related salts, are to
provide desirable handling characteristics of the devices,
especially in the wet environment of the surgical field.
[0008] Another aspect of the invention is the process of
incorporating triclosan into the absorbable sutures by any or
combinations of following methods: coating the absorbable sutures
with a mixture comprising triclosan, which is either added into the
coating mixture or incorporated into the coating carrier polymers,
one or more absorbable carrier polymers with or without triclosan
and one or more fatty acid salts, in the form of calcium or sodium
salts or esters and related salts; or treating the absorbable
sutures with a solution of triclosan, and then coating with a
mixture comprising one or more absorbable carrier polymers and one
or more fatty acid salts, in the form of calcium or sodium salts or
esters and related salts, with or without triclosan; or formulating
triclosan into the absorbable sutures by adding triclosan into the
polymerization reaction or blending triclosan into the absorbable
polymers, spinning and braiding and then coating with a mixture
comprising one or more absorbable carrier polymers and one or more
fatty acid salts, in the form of calcium or sodium salts or esters
and related salts, with or without triclosan.
EXAMPLE 1
[0009] Polysorb* absorbable suture (Lactomer 9-1, U. S. Surgical,
Norwalk, Conn.), size 2/0, was coated with a mixture of equal parts
of copolymers of glycolide and lactide and calcium stearate
containing various levels of triclosan. The coated antimicrobial
sutures were cut into 5 cm pieces and extracted with 0.85% saline
and incubated at 37.degree. for 24 hrs; 48 hrs and 72 hrs. The
extracted sutures and the non-extracted ones were dried and then
placed aseptically in sterile Petri dishes and challenged with 100
uL of inoculum containing 10.sup.5 colony-forming units (CFU) of S.
aureus. Tryptic soy agar was poured into each dish and then
incubated for 37.degree. C. for 48 hrs. After incubation, the
plates were examined for zones of inhibition measurements.
EXAMPLE 2
[0010] Polysorb* absorbable suture (Lactomer 9-1, U. S. Surgical,
Norwalk, Conn.), size 2/0, was treated with 2.0% solution of
triclosan and then heated at 65.degree. C. for 2 minutes. The
triclosan-treated sutures were further coated with a mixture of
equal parts of copolymers of glycolide and lactide and calcium
stearate without or with various levels of triclosan. A similar
extraction and zones of inhibition measurement method in Example 1
were used to compare antimicrobial activities. It was found that
the treated sutures had longer antimicrobial activity retention
than the simple triclosan coated sutures from saline extraction,
indicating slower releasing profile of triclosan in the aqueous
medium.
EXAMPLE 3
[0011] Un-coated absorbable suture braids (Samyang Corporation,
South Korea), size 2/0, were treated with a solution of 1.8%
triclosan in methylene chloride and then dried. The triclosan
treated sutures were further coated with a coating solution
containing triclosan (1.8%). The control samples were only coated
with the same coating solution containing triclosan. The
triclosan-treated and then triclosan-coated sutures had longer
antimicrobial activities than only triclosan-coated sutures.
EXAMPLE 4
[0012] A batch of 5.0 kg of copolymer of 90% glycolide and 10%
lactide is divided into two equal portions. The first portion is
mixed under nitrogen with a solution of 1% triclosan and then
heated at 65.degree. C. under vacuum, resulting in a total 600 ppm
triclosan in the polymer. The second portion is used as control.
Both portions are spun into fibers under same conditions and the
resulted fibers from both have similar physical properties.
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